A Multicenter, Double-Blind, Randomized, Placebo-Controlled, 12-Week, Dose-Range-Finding Trial of YKP10811 Capsules Administered Once Daily to Subjects With Chronic Idiopathic Constipation



Status:Recruiting
Conditions:Constipation
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 65
Updated:5/5/2014
Start Date:October 2013
Contact:Lin-Ming Shen, PhD
Email:lin-ming@sk.com
Phone:201-421-3811

Use our guide to learn which trials are right for you!

This will be a multi-center, randomized, double-blind, placebo-controlled study of YKP10811
capsules in patients with chronic idiopathic constipation. Following a 2-week baseline
period, approximately 320 eligible patients with <3 complete spontaneous bowel movements
(CSBM) and ≤ 5 SBMs per week will be randomly assigned equally to receive one of the
following oral treatments; placebo or YKP10811 capsules once daily for 12 weeks followed by
a 2 week follow-up period.

The objectives of this study are:

- To assess the efficacy of YKP10811 once daily at relieving constipation and associated
symptoms in subjects with chronic idiopathic constipation.

- To determine the safety and tolerability of YKP10811 once daily in subjects with
chronic idiopathic constipation.


Inclusion Criteria:

- Patients who meet modified Rome II criteria for Chronic Constipation.

- Patients who are male or female, 18 to 65 years of age inclusive.

- At Visit 3, patients must have < 3 CSBMs per week and ≤ 5 SBMs per week during the
2-week baseline period.

Exclusion Criteria:

- Patients who meet Rome II criteria for Irritable Bowel Syndrome (IBS-C).

- Patients with constipation that is drug-induced, or secondary to endocrine, metabolic
or, surgery.

- Patients with a clinically significant diseases that would limit the patient's
ability to complete and/or participate in the study, including gastrointestinal
disorder or surgery, an endocrine abnormality (e.g., diabetes), impaired renal
function (GFR of < 55mL/minute/1.73m2), uncontrolled pulmonary diseases (including
asthma), uncontrolled cardiovascular disease (a history of myocardial infarction or
cerebrovascular accident within 6 months prior to screening) or significant
neurological diseases.

- Patients with a history of inflammatory bowel disease.

- Patients with a history of cancer (other than basal cell or squamous cell carcinoma
of the skin completely excised) unless the malignancy has been in complete remission
for at least 5 years prior to screening.

- Patients who started a special diet and/or an intense physical workout program within
30 days prior to the beginning of the baseline period or who are intending to
substantially modify their dietary habits at any time during the study (patients on a
stable, continuous regimen of fiber therapy for at least 30 days prior to the
pretreatment baseline period are allowed to continue that therapy, provided that they
continue at a constant dose throughout the study.

- Patients with a history of clinically significant hypersensitivity or allergy (facial
swelling, hives, breathing difficulty, Stevens-Johnson syndrome etc), in response to
any medication, either prescription or nonprescription including an investigational
drug, dietary supplement, or herbal medicine.
We found this trial at
72
sites
Weymouth, Massachusetts 02190
?
mi
from
Weymouth, MA
Click here to add this to my saved trials
99 N. Brice Rd
Columbus, Ohio 43068
614-501-6164
?
mi
from
Columbus, OH
Click here to add this to my saved trials
610 3rd St # 206
Macon, Georgia 31201
?
mi
from
Macon, GA
Click here to add this to my saved trials
1904 East Barnett Road
Medford, Oregon 97504
541-973-2080
?
mi
from
Medford, OR
Click here to add this to my saved trials
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
Anderson, South Carolina 29621
?
mi
from
Anderson, SC
Click here to add this to my saved trials
1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
?
mi
from
Austin, TX
Click here to add this to my saved trials
Beaumont, Texas 77702
?
mi
from
Beaumont, TX
Click here to add this to my saved trials
Beavercreek, Ohio 45440
?
mi
from
Beavercreek, OH
Click here to add this to my saved trials
Birmingham, Alabama 35215
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Blue Ridge, Georgia 30513
?
mi
from
Blue Ridge, GA
Click here to add this to my saved trials
Bradenton, Florida
?
mi
from
Bradenton, FL
Click here to add this to my saved trials
2001 Oriental Boulevard
Brooklyn, New York 11235
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
Charlotte, North Carolina 28209
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Chicago, Illinois 60624
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Chula Vista, California 91910
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cincinnati, Ohio 45242
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Clarksville, Tennessee 37043
?
mi
from
Clarksville, TN
Click here to add this to my saved trials
Clearwater, Florida 33759
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Concord, North Carolina 28025
?
mi
from
Concord, NC
Click here to add this to my saved trials
Cumberland, Rhode Island 02864
?
mi
from
Cumberland, RI
Click here to add this to my saved trials
Egg Harbor Township, New Jersey 08234
?
mi
from
Egg Harbor Township, NJ
Click here to add this to my saved trials
El Cajon, California 92020
?
mi
from
El Cajon, CA
Click here to add this to my saved trials
Encinitas, California 92024
?
mi
from
Encinitas, CA
Click here to add this to my saved trials
Evansville, Indiana 47714
?
mi
from
Evansville, IN
Click here to add this to my saved trials
Evergreen Park, Illinois 60805
?
mi
from
Evergreen Park, IL
Click here to add this to my saved trials
Henderson, Nevada 89052
?
mi
from
Henderson, NV
Click here to add this to my saved trials
Hialeah, Florida 33012
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
Hickory, North Carolina 28602
?
mi
from
Hickory, NC
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Laguna Hills, California 92653
?
mi
from
Laguna Hills, CA
Click here to add this to my saved trials
Las Vegas, Nevada 89119
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Las Vegas, Nevada 89104
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Lincoln, California 95648
?
mi
from
Lincoln, CA
Click here to add this to my saved trials
Little Rock, Arkansas 72212
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Marietta, Georgia 30060
?
mi
from
Marietta, GA
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33125
?
mi
from
Miami, FL
Click here to add this to my saved trials
Naples, Florida 34119
?
mi
from
Naples, FL
Click here to add this to my saved trials
Natchitoches, Louisiana 71457
?
mi
from
Natchitoches, LA
Click here to add this to my saved trials
New York, New York 10004
?
mi
from
New York, NY
Click here to add this to my saved trials
Newport News, Virginia 23606
?
mi
from
Newport News, VA
Click here to add this to my saved trials
Norfolk, Virginia 23502
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Oceanside, California 92056
?
mi
from
Oceanside, CA
Click here to add this to my saved trials
Ogden, Utah 84405
?
mi
from
Ogden, UT
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73103
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Palm Harbor, Florida 34684
?
mi
from
Palm Harbor, FL
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Phoenix, Arizona 85023
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15206
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
Rapid City, South Dakota 57702
?
mi
from
Rapid City, SD
Click here to add this to my saved trials
Sacramento, California
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
San Antonio, Texas
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Antonio, Texas 78215
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Springfield, Massachusetts 01107
?
mi
from
Springfield, MA
Click here to add this to my saved trials
St. Louis, Missouri 63141
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
Stamford, Connecticut 06095
?
mi
from
Stamford, CT
Click here to add this to my saved trials
2713 West Virginia Avenue
Tampa, Florida 33607
(813) 873-8102
Clinical Research Trials of Florida, Inc (CRTFI) is located across of St Joseph Hospital the...
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Towson, MD
Click here to add this to my saved trials
Tulsa, Oklahoma 74137
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
?
mi
from
Tyler, TX
Click here to add this to my saved trials
1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103
(336) 768-8062
PMG Research of Winston-Salem PMG Research of Winston-Salem, founded in 1979, occupies a 10,000 square...
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials
Woodstock, Georgia 30189
?
mi
from
Woodstock, GA
Click here to add this to my saved trials